510(k) · Cleared
ClearedPolaris Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Design & Manufacturing Corp. · LRX Case, Contact Lens
Cleared on Apr 27, 2010 as substantially equivalent to K071081 (Ningbo Kaida Rubber and Plastic Technology Co., LT, 2007) after a 180-day review. Its family tree reaches back 3 generations to 1992. 11 later devices descend from it.
- Decided
- Apr 27, 2010
- Review
- 180 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920064 (1992). 4 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 2 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 1 generation backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- This deviceK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
- Descendant · cites it directly · 9 of its ownK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
- Descendant · 2 generations on · 5 of its ownK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK142717 Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact…Ni Hau Industrial Co., Ltd. · 2015
- Descendant · 4 generations on · 1 of its ownK162869 Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012 · cites it directly9descendants
- K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014 · 2 generations on5descendants
- K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd. · 2024 · 2 generations on2descendants
- K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye…Ni Hau Industrial Co., Ltd. · 2015 · 3 generations on2descendants
- K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −2 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −1 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| 0 (this device) | K093377 | Polaris Contact Lens Case | Reliance Design & Manufacturing Corp. | 2010 | — |
| +1 | K120904 | Polaris Dial-a-Date Contact Lens Case | Reliance Design & Manufacture Corp. | 2012 | — |
| +2 | K130930 | Owl Contact Lens Cases, Dog Contact Lens Cases | Ningbo Lishunda Electronics Co., Ltd. | 2014 | — |
| +2 | K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. | 2024 | — |
| +3 | K142717 | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case… | Ni Hau Industrial Co., Ltd. | 2015 | — |
| +4 | K162869 | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071081 | Contact Lens CaseSummary page 1…da Rubber & Plastic Technology Co., Ltd. Classification Name: Soft (hydrophilic) contact lens care products (886.5928) Classification: Class II 510(k) Number: K071081 Device Description PolarisContact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas penneable contact l… | 2007 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120904 (Reliance Design & Manufacture Corp., 2012) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K071081.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093377: Polaris Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093377
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026